Hypotension, OrthostaticNCT01866787
Study on Baroreceptor Function in Relation to Orthostatic Blood Pressure Regulation After Hip Surgery
An observational study of Hypotension, Orthostatic and Total Hip Replacement, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this observational study is to evaluate the baroreceptor function in relation to surgical inflammation and orthostatic intolerance after elective hip arthroplasty. The main hypothesis is that baroreceptor function is attenuated after surgery and related to surgical inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension, Orthostatic, Total Hip Replacement
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective unilateral hip arthroplasty at Frederiksberg Hospital.
Who may be able to join
- Scheduled for unilateral hip arthroplasty
- 18 years or older
- Able to give informed consent
Who cannot join
- American Society of Anesthesiologists (ASA) class 3 or higher
- Chronic arrythmia (Atrial fibrillation or other arrythmia)
- Incompensated ischaemic heart disease
- Mobilization restriction due to surgical reasons
- Medical complications during admission requiring transferral to other department
Trial locations and contacts
1 site in 1 country.
Øivind Jans, M.D contact
Denmark1 site, 1 recruiting
- Recruiting
Frederiksberg Hospital, Department of orthopaedic surgery
Frederiksberg, 2000
Arne Borgwardt, M.D., Arne.Borgwardt@regionh.dk
Øivind Jans, M.D.
About this study
Official title: Baroreceptor Function and Inflammation in Relation to Orthostatic Intolerance During Early Mobilization After Elective Hip Arthroplasty
The purpose of this observational study is to evaluate the baroreceptor function in relation to surgical inflammation and orthostatic intolerance after elective hip arthroplasty.
The main hypothesis is that baroreceptor function is attenuated after surgery and related to surgical inflammation.
Read the detailed description
Orthostatic intolerance and hypotension is prevalent during early mobilization after major surgery.
This observational study aims to evaluate the baroreceptor function during using a standardized evaluation protocol before, 6- and 24 hours after elective primary unilateral hip-arthroplasty.
The study hypothesis is that baroreceptor function as expressed by the valsalva ratio is attenuated after surgery and related to surgical inflammation.
- Conditions
- Hypotension, Orthostatic, Total Hip Replacement
- Keywords
- Postoperative orthostatic intolerance, Surgical inflammatory response
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baroreceptor function from preoperatively to 6 hours after surgery
Change in baroreceptor function as expressed by change in the blood pressure valsalva ratio during a standardized assessment before and 6 hours after surgery.
Measured: 6 hours after surgery
Secondary outcomes (6)
Orthostatic response in blood pressure
The response in systolic and diastolic blood pressure during postural change from supine to standing
Measured: Preoperative, 6 and 24 hours after surgery
Orthostatic response in heart rate variability
Heart rate variability during supine rest, sitting and standing as assessed by Spectral analysis.
Measured: preoperative, 6 and 24 hours postoperative
Orthostatic intolerance
Orthostatic intolerance defined as the inability to sit or stand for 3 minutes due to presyncopal symptoms (Dizziness, Nausea, Blurred vision).
Measured: preoperative, 6 and 24 hours after surgery
Inflammatory markers
Inflammatory markers (CRP and interleukin-6) measured at 3 separate timepoint: preoperative, 6- and 24 h after surgery
Measured: preoperative, 6 and 24 hours postoperative
Orthostatic Hypotension
orthostatic hypotension defined according to international guidelines.
Measured: Preoperative, 6 and 24 hours postoperative.
Baroreceptor function
baroreceptor function as expressed by change in the blood pressure valsalva ratio during a standardized assessment
Measured: On the day of surgery: preoperatively, 6- and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension, OrthostaticStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Principal investigator, Oeivind Jans, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Øivind Jans, M.D, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866787
- Sponsor's protocol ID
- RH-4074-OJ3
- Status last verified
- Jan 2015
- First submitted
- 4 Feb 2013
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baroreceptor Function and Inflammation in Relation to Orthostatic Intolerance During Early Mobilization After Elective Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01866787
- Acronym / sponsor ID
- RH-4074-OJ3
- Conditions
- Hypotension, Orthostatic, Total Hip Replacement
- Keywords
- Postoperative orthostatic intolerance, Surgical inflammatory response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study is to evaluate the baroreceptor function in relation to surgical inflammation and orthostatic intolerance after elective hip arthroplasty.
The main hypothesis is that baroreceptor function is attenuated after surgery and related to surgical inflammation.
Detailed description
Orthostatic intolerance and hypotension is prevalent during early mobilization after major surgery.
This observational study aims to evaluate the baroreceptor function during using a standardized evaluation protocol before, 6- and 24 hours after elective primary unilateral hip-arthroplasty.
The study hypothesis is that baroreceptor function as expressed by the valsalva ratio is attenuated after surgery and related to surgical inflammation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective unilateral hip arthroplasty at Frederiksberg Hospital.
Key inclusion criteria (3 listed)
- Scheduled for unilateral hip arthroplasty
- 18 years or older
- Able to give informed consent
Key exclusion criteria (5 listed)
- American Society of Anesthesiologists (ASA) class 3 or higher
- Chronic arrythmia (Atrial fibrillation or other arrythmia)
- Incompensated ischaemic heart disease
- Mobilization restriction due to surgical reasons
- Medical complications during admission requiring transferral to other department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in baroreceptor function from preoperatively to 6 hours after surgery
Time frame: 6 hours after surgery
Change in baroreceptor function as expressed by change in the blood pressure valsalva ratio during a standardized assessment before and 6 hours after surgery.
6 secondary outcomes
Orthostatic response in blood pressure
Time frame: Preoperative, 6 and 24 hours after surgery
Orthostatic response in heart rate variability
Time frame: preoperative, 6 and 24 hours postoperative
Orthostatic intolerance
Time frame: preoperative, 6 and 24 hours after surgery
Inflammatory markers
Time frame: preoperative, 6 and 24 hours postoperative
Orthostatic Hypotension
Time frame: Preoperative, 6 and 24 hours postoperative.
Baroreceptor function
Time frame: On the day of surgery: preoperatively, 6- and 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øivind Jans, M.D contact
Øivind Jans, M.D principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension, Orthostatic and Total Hip Replacement, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Øivind Jans, M.D (oeivind.jans@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baroreceptor function from preoperatively to 6 hours after surgery (time frame: 6 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.